Randomized Evaluation of Default Access to Palliative Services

COPD Clinical Trial

— REDAPS  

Official title:

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505035
• Other study ID #: 822134
• Secondary ID: UH2AG050311
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 2020

Study information

• Verified date: September 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.

Description:

The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients. The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS. To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record. Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services. Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart. During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services. By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months. The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34239
• Est. completion date: September 2020
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Age 65 years or older

2. Current hospitalization of at least 3 calendar days (modified ITT)

3. Diagnosis of one or more of the following:

• End-stage renal disease (ESRD) on dialysis

• Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months

• Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months

Exclusion criteria:

1. Patients younger than 65 years old will not receive the intervention

Related Conditions & MeSH terms

• COPD
• Dementia
• ESRD

Intervention

Behavioral:
• Default ordering of palliative consult

Locations

Country	Name	City	State
United States	University Medical Center Brackenridge	Austin	Texas
United States	Our Lady of Lourdes Memorial Hospital	Binghamton	New York
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	St. Vincent's Medical Center, Riverside	Jacksonville	Florida
United States	St. Vincent's Medical Center, Southside	Jacksonville	Florida
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	Columbia St. Mary's, Ozaukee	Mequon	Wisconsin
United States	Columbia St. Mary's, North Lake	Milwaukee	Wisconsin
United States	St. Thomas West Hospital	Nashville	Tennessee
United States	Via Christi Hospital, St. Francis	Wichita	Kansas
United States	Via Christi Hospital, St. Joseph	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Measure: Length of Stay and In-Hospital Mortality	The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution. Data is extracted from the electronic health record.	Duration of hospital stay, an expected average of 8 days
Secondary	Goals of care assessment	Documented assessments of patients' goals of care within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Pain assessment	Documented assessments of patients' pain scores within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Dyspnea assessment	Documented assessments of patients' dyspnea within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Code status	Code status documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Mechanical ventilation	Documented orders for mechanical ventilation within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Cardiopulmonary resuscitation	Documented orders for cardiopulmonary resuscitation within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Inpatient dialysis	Documented orders for dialysis during inpatient stay within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	ICU admission	Transferal to an intensive care unit documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Hospital discharge status	Hospital discharge disposition code documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Discharge planning orders	Discharge orders for home care services documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Secondary	Hospital readmission	30-day hospital re-admissions documented within the Premier database	30 days
Secondary	Direct cost per day	Direct cost per day documented within the Premier database	Duration of hospital stay, an expected average of 8 days
Secondary	Direct cost per hospitalization	Direct cost per hospitalization documented within the Premier database	Duration of hospital stay, an expected average of 8 days